Hypertension (HTN)MULTI-HEARTSNCT07536919
Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation
A study testing HEARTS implementation strategies and Supply chain strengthening in people with Hypertension (HTN) and Type 2 Diabetes, run by University of Michigan.
Trial summary
The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), Type 2 Diabetes
- What is being tested?
- HEARTS implementation strategies and Supply chain strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2027to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Systolic blood pressure ≥130 mmHg on ≥2 occasions, defined as the mean of 6 measurements at 2 study visits scheduled at least 1 day apart but within 7 days
- Hemoglobin A1c ≥6.5%
- Able and willing to provide informed consent
Who cannot join
- Does not live in Health Center's catchment area or is unwilling to receive care at the Health Center
- Currently pregnant or planning pregnancy in the next 2 years
- Has been diagnosed with type 1 diabetes, or there is high suspicion of this diagnosis by study physicians
- Has severe chronic or terminal illness such that primary care management of hypertension and/or diabetes would be clinically inappropriate, including end-stage kidney disease
- Confined to bed
- Planning to leave the study area in the next 2 years
- Unwilling to comply with protocol requirements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation (MULTI-HEARTS)
The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).
Read the detailed description
Hypertension and diabetes frequently co-occur and together are a leading cause of death and disability. Despite the availability of effective treatments, many patients remain untreated or uncontrolled. HEARTS is a package of implementation strategies recommended by the World Health Organization and Pan American Health Organization to improve cardiovascular disease management in primary care. To date, most HEARTS projects have focused on hypertension alone, and rigorous evaluations of HEARTS for integrated hypertension and diabetes care are lacking.
This cluster-randomized trial will be conducted in 36 Ministry of Health primary care facilities (Health Centers) in Guatemala. Health Centers will be randomized 1:1 to HEARTS or enhanced usual care. The HEARTS intervention consists of five implementation strategies adapted to Guatemala: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols; (3) strengthening supply chains of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The comparator arm receives enhanced usual care, which includes standard Ministry of Health clinical care plus supply chain strengthening to ensure between-arm differences are not attributable to medication availability.
Approximately 1,440 patients with hypertension-diabetes multimorbidity (40 per facility) will be enrolled and assessed at baseline and 12 months. Co-primary outcomes are change in systolic blood pressure and hemoglobin A1c. Secondary outcomes include diastolic blood pressure, and proportions achieving blood pressure control (<130/<80 mmHg), hemoglobin A1c control (<7.0%), and combined control. A cost-effectiveness and budget impact analysis will be conducted from the health care sector perspective. The implementation period is 30 months, followed by a 12-month maintenance period.
- Conditions
- Hypertension (HTN), Type 2 Diabetes
- Being tested
- HEARTS implementation strategies, Supply chain strengthening
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARTS implementation strategiesOther
A package of five multilevel implementation strategies based on the WHO/PAHO Hearts Technical Package, adapted to Guatemala: (1) Training and supportive supervision for health workers on evidence-based hypertension and diabetes treatment protocols; (2) Simplifying treatment protocols; (3) Strengthening supply chains of a core set of medications and supplies; (4) Task sharing with non-physician health workers; (5) Implementing quality monitoring systems using standardized registries and indicators.
Supply chain strengtheningOther
Strengthening supply chains of a core set of medications and supplies for hypertension and diabetes care. This strategy is provided to both arms to ensure that observed between-arm differences are attributable to the other HEARTS implementation strategies rather than to variations in medication and supply availability.
| Study group | Role | What they receive |
|---|---|---|
| HEARTS Integrated Hypertension-Diabetes Care | Experimental | Health Centers in the experimental arm receive a package of five multilevel HEARTS implementation strategies adapted to Guatemala for integrated hypertension-diabetes multimorbidity care: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols for hypertension and diabetes; (3) strengthening supply chains of a core set of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The implementation period is 30 months, followed by a 12-month maintenance period. Receives: Other: HEARTS implementation strategies; Other: Supply chain strengthening |
| Enhanced Usual Care | Active comparator | Health Centers in the comparator arm receive enhanced usual care consisting of standard clinical care and medications for hypertension and diabetes available through the Ministry of Health system, aligned with national clinical guidelines. As an enhancement to usual care, comparator Health Centers also receive the strategy to strengthen supply chains of medications and supplies. This enhancement ensures that between-arm differences are not due to variations in clinical resource availability and minimizes the risk of contamination, as supply chain management in the MOH system occurs at multiple levels. Receives: Other: Supply chain strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Between-arm mean difference in change in systolic blood pressure (mmHg)
Measured: Enrollment to 12 months
Change in hemoglobin A1c
Between-arm mean difference in change in hemoglobin A1c (%)
Measured: Enrollment to 12 months
Secondary outcomes (4)
Change in diastolic blood pressure
Between-arm mean difference in change in diastolic blood pressure (mmHg)
Measured: Enrollment to 12 months
Proportion with blood pressure control
Between-arm difference in proportion achieving blood pressure <130/<80 mmHg
Measured: Enrollment to 12 months
Proportion with hemoglobin A1c control
Between-arm difference in proportion achieving HbA1c <7.0%
Measured: 12 months
Proportion with combined blood pressure and hemoglobin A1c control
Between-arm difference in proportion achieving blood pressure <130/<80 mmHg and HbA1c <7.0%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2027 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Flood, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536919
- Sponsor's protocol ID
- HL183254
- Acronym
- MULTI-HEARTS
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data from the clinical trial will be shared via the NHLBI BioLINCC repository. Data will include sociodemographics, anthropometrics, medical history, blood pressure, hemoglobin A1c, and self-reported outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation (MULTI-HEARTS)
- ClinicalTrials.gov ID
- NCT07536919
- Acronym / sponsor ID
- MULTI-HEARTS / HL183254
- Conditions
- Hypertension (HTN), Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).
Detailed description
Hypertension and diabetes frequently co-occur and together are a leading cause of death and disability. Despite the availability of effective treatments, many patients remain untreated or uncontrolled. HEARTS is a package of implementation strategies recommended by the World Health Organization and Pan American Health Organization to improve cardiovascular disease management in primary care. To date, most HEARTS projects have focused on hypertension alone, and rigorous evaluations of HEARTS for integrated hypertension and diabetes care are lacking.
This cluster-randomized trial will be conducted in 36 Ministry of Health primary care facilities (Health Centers) in Guatemala. Health Centers will be randomized 1:1 to HEARTS or enhanced usual care. The HEARTS intervention consists of five implementation strategies adapted to Guatemala: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols; (3) strengthening supply chains of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The comparator arm receives enhanced usual care, which includes standard Ministry of Health clinical care plus supply chain strengthening to ensure between-arm differences are not attributable to medication availability.
Approximately 1,440 patients with hypertension-diabetes multimorbidity (40 per facility) will be enrolled and assessed at baseline and 12 months. Co-primary outcomes are change in systolic blood pressure and hemoglobin A1c. Secondary outcomes include diastolic blood pressure, and proportions achieving blood pressure control (<130/<80 mmHg), hemoglobin A1c control (<7.0%), and combined control. A cost-effectiveness and budget impact analysis will be conducted from the health care sector perspective. The implementation period is 30 months, followed by a 12-month maintenance period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEARTS Integrated Hypertension-Diabetes Care | Experimental | Other: HEARTS implementation strategies, Other: Supply chain strengtheningHealth Centers in the experimental arm receive a package of five multilevel HEARTS implementation strategies adapted to Guatemala for integrated hypertension-diabetes multimorbidity care: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols for hypertension and diabetes; (3) strengthening supply chains of a core set of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The implementation period is 30 months, followed by a 12-month maintenance period. |
| Enhanced Usual Care | Active comparator | Other: Supply chain strengtheningHealth Centers in the comparator arm receive enhanced usual care consisting of standard clinical care and medications for hypertension and diabetes available through the Ministry of Health system, aligned with national clinical guidelines. As an enhancement to usual care, comparator Health Centers also receive the strategy to strengthen supply chains of medications and supplies. This enhancement ensures that between-arm differences are not due to variations in clinical resource availability and minimizes the risk of contamination, as supply chain management in the MOH system occurs at multiple levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Systolic blood pressure ≥130 mmHg on ≥2 occasions, defined as the mean of 6 measurements at 2 study visits scheduled at least 1 day apart but within 7 days
- Hemoglobin A1c ≥6.5%
- Able and willing to provide informed consent
Key exclusion criteria (7 listed)
- Does not live in Health Center's catchment area or is unwilling to receive care at the Health Center
- Currently pregnant or planning pregnancy in the next 2 years
- Has been diagnosed with type 1 diabetes, or there is high suspicion of this diagnosis by study physicians
- Has severe chronic or terminal illness such that primary care management of hypertension and/or diabetes would be clinically inappropriate, including end-stage kidney disease
- Confined to bed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEARTS implementation strategiesA package of five multilevel implementation strategies based on the WHO/PAHO Hearts Technical Package, adapted to Guatemala: (1) Training and supportive supervision for health workers on evidence-based hypertension and diabetes treatment protocols; (2) Simplifying treatment protocols; (3) Strengthening supply chains of a core set of medications and supplies; (4) Task sharing with non-physician health workers; (5) Implementing quality monitoring systems using standardized registries and indicators. | Other | HEARTS Integrated Hypertension-Diabetes Care |
| Supply chain strengtheningStrengthening supply chains of a core set of medications and supplies for hypertension and diabetes care. This strategy is provided to both arms to ensure that observed between-arm differences are attributable to the other HEARTS implementation strategies rather than to variations in medication and supply availability. | Other | Enhanced Usual Care, HEARTS Integrated Hypertension-Diabetes Care |
Primary outcome
Change in systolic blood pressure
Time frame: Enrollment to 12 months
Between-arm mean difference in change in systolic blood pressure (mmHg)
Change in hemoglobin A1c
Time frame: Enrollment to 12 months
Between-arm mean difference in change in hemoglobin A1c (%)
4 secondary outcomes
Change in diastolic blood pressure
Time frame: Enrollment to 12 months
Proportion with blood pressure control
Time frame: Enrollment to 12 months
Proportion with hemoglobin A1c control
Time frame: 12 months
Proportion with combined blood pressure and hemoglobin A1c control
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data from the clinical trial will be shared via the NHLBI BioLINCC repository. Data will include sociodemographics, anthropometrics, medical history, blood pressure, hemoglobin A1c, and self-reported outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing HEARTS implementation strategies and Supply chain strengthening in people with Hypertension (HTN) and Type 2 Diabetes, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Flood, MD (734-647-2892, dcflood@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: Enrollment to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.